BEMFOLA follitropin alfa (rch) 300 IU/0.5 mL (22 microgram) solution for injection cartridge in a pre-filled pen

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Follitropin alfa, Quantity: 300 IU

Available from:

Gedeon Richter Australia Pty Ltd

INN (International Name):

Follitropin alfa

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: poloxamer; sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; methionine; phosphoric acid; thymidine; Trypsin

Administration route:

Subcutaneous

Units in package:

5, 1, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

In adult women:,- Bemfola is indicated for the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated,- Controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies,- Bemfola in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/L.,In adult men:,- Bemfola is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-11-27

Patient Information leaflet

Consumer Medicine Information
Bemfola
Gedeon Richter
June 2019
1
BEMFOLA®
_Recombinant human follicle stimulating hormone (follitropin alfa
[rch]) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Bemfola.
It does not contain all the
available information.
It does not take the place of
talking to your doctor, nurse or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
Bemfola against the benefits it
is expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS INFORMATION WITH
YOUR MEDICINE.
You may need to read it again
later.
WHAT IS BEMFOLA USED
FOR
Bemfola contains follitropin
alfa, which is similar to follicle
stimulating hormone (FSH)
found naturally in humans.
Bemfola belongs to a class of
hormones called
gonadotrophins. FSH is
necessary for the growth and
development of egg cells
(follicles) in women, and sperm
production in men.
Bemfola is an approved
biosimilar to the reference
product Gonal-f®.
Comparability in safety,
efficacy and quality between
Bemfola and Gonal-f® have
been established.
IN WOMEN
Bemfola can be used to bring
about the development of
follicles in women who are not
ovulating and who have not
responded to treatment with
clomiphene citrate.
Bemfola is also used to
stimulate the development of
several follicles in women
undergoing assisted
reproductive technologies
(ART) such as _in vitro_
fertilisation (IVF).
Bemfola can be used together
with another hormone called
Luteinising Hormone (LH) to
stimulate development of
follicles in women who have
been shown to produce very
low levels of some of the
hormones involved in the
natural reproductive cycle.
IN MEN
Bemfola is used in combination
with human chorionic
gonadotrophin (hCG) to
stimulate the production of
sperm.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
BEMFOLA HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
prescribed it for another
reason.
Bemfola is av

Summary of Product characteristics

GEDEON RICHTER
Page 1 of 16
AUSTR 231039; AUSTR 231046, AUSTR 231051, AUSTR 231052, AUSTR 231053
AUSTRALIAN PRODUCT INFORMATION
BEMFOLA® (FOLLITROPIN ALFA (RCH)) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
follitropin alfa (rch)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BEMFOLA is a biosimilar medicinal product, i.e. a medicine that has
been demonstrated to be similar
in quality, safety and efficacy to the reference medicinal product
GONAL-f®.
BEMFOLA contains the active ingredient follitropin alfa (rch). This is
produced by a Chinese Hamster
Ovary cell line transfected with the human FSH subunit genes (i.e. by
recombinant DNA technology).
Clear glass cartridges containing BEMFOLA solution for injection are
designed for subcutaneous
injection pre-assembled in a disposable pen. BEMFOLA is available as
solution for injection,
containing follitropin alfa (rch) 75 IU/0.125 mL (5.5 micrograms/0.125
mL), 150 IU/0.25 mL (11
micrograms/0.25 mL), 225 IU/0.375 mL (16.5 micrograms/0.375 mL), 300
IU/0.5 mL (22
micrograms/0.5 mL) or 450 IU/0.75 mL (33 micrograms/0.75 mL) in
pre-filled pens.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
BEMFOLA is a clear, colourless solution for injection for subcutaneous
injection pre-assembled in a
disposable pen.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In adult women:

BEMFOLA is indicated for the treatment of anovulatory infertility in
women who have been
unresponsive to clomiphene citrate or where clomiphene citrate is
contraindicated.

Controlled ovarian hyperstimulation in women undergoing assisted
reproductive
Technologies

BEMFOLA in association with a luteinising hormone (LH) preparation is
recommended for
the stimulation of follicular development in women with severe LH and
FSH deficiency. In
clinical trials these patients were defined by an endogenous serum LH
level <1.2 IU/l.
In adult men:

BEMFOLA is indicated with concomitant human chorionic gonadotrophin
(hCG) therapy for
the stimulation of spermatoge